Technical Director - Biocompatibility

About the role

The Technical Director - Biocompatibility is responsible for providing scientific, strategic, and commercial leadership for Product Safety Labs' (PSL) medical device biocompatibility business. The position will serve as a senior scientific authority in biological evaluation and biocompatibility testing and will help establish PSL as a recognized industry leader while supporting significant growth of the business.

The Technical Director will work closely with Study Directors, laboratory management, business development personnel, and executive leadership to strengthen PSL's scientific capabilities, mentor technical staff, support strategic client relationships, expand the scope of services offered, and identify opportunities for profitable growth. Study Directors will retain responsibility for the conduct of assigned studies in accordance with applicable regulations, protocols, and PSL procedures.

The position will represent PSL through client engagement, scientific presentations, publications, professional organizations, standards committees, conferences, and other industry activities. The Technical Director will collaborate closely with Eurofins Medical Device team members, particularly the Lancaster organization, and with other Eurofins laboratories in North America and Europe, as appropriate.

This position may be remote. Regular travel to PSL, other Eurofins locations, client sites, conferences, and industry meetings will be required.

Qualifications & Requirements

• Advanced degree in biology, toxicology, biomedical engineering, materials science, pharmacology, or another scientific discipline relevant to medical device biological evaluation. Ph.D. or equivalent terminal degree preferred.
• Minimum 10 years of progressively responsible experience in medical device biocompatibility, biological evaluation, regulatory science, or a closely related field; 15 or more years strongly preferred.
• Demonstrated recognition within the medical device industry as a biocompatibility or biological evaluation subject matter expert.
• Intimate working familiarity with the ISO 10993 series, including biological evaluation within a risk management process; test selection and interpretation; sample preparation; chemical characterization; toxicological risk assessment integration; and applicable biological endpoints.
• Strong working knowledge of current FDA biocompatibility guidance and expectations (including ASCA requirements), Regulation (EU) 2017/745, ISO 17025 and applicable GLP requirements, and other international medical device requirements.
• Demonstrated ability to develop and communicate scientifically sound biological evaluation strategies and to resolve complex technical and regulatory questions.
• Established record of scientific presentations, publications, standards involvement, professional organization participation, or comparable industry leadership.
• Demonstrated ability to support business growth through technical consultation, client engagement, service development, and collaboration with business development teams.
• Experience working in a contract research organization, testing laboratory, medical device manufacturer, regulatory authority, or comparable environment preferred.
• Excellent written, verbal, presentation, leadership, and interpersonal skills.
• Ability to work effectively in a remote leadership role and to travel as required.
• Strong computer skills.
• He/she must have a current tetanus vaccination.

Additional Information

Positions are full-time, Monday-Friday 8am-5pm. Candidates currently living within commutable distance to South Brunswick Township, NJ are encouraged to apply.

Compensation

$160,000 - $180,000 depending on related experience and qualification.

Excellent full time benefits including

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays